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Regulatory Affairs Manager

Kelly Services


Location:
Round Lake, IL
Date:
04/25/2018
2018-04-252018-05-24
Job Code:
US33MXGR_BH1414882
Categories:
  • Government
  • Regulatory Affairs
Kelly Services
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Job Details

Job Title Regulatory Affairs Manager

Jobid US33MXGR_BH1414882

Location: Round Lake, IL, 60073, USA

Description Kelly Services is seeking a **Regulatory Affairs Manager** for our customer in **Round Lake, IL** currently budgeted through the end of the year. This position on the Regulatory team is accountable for the relationship with the US Food and Drug Administration, along with other relevant regulatory bodies, and is responsible for the local execution of regulatory initiatives in line with business goals.

The Regulatory Affairs Manager is responsible for defining regulatory strategies and submissions in support of new and existing marketing authorizations for products for one or more business units/countries. **Candidate must have experience in US drug submissions (NOT MEDICAL DEVICE)** , owned and authored submissions to the FDA.; change control in US drug products including assessment, analysis, etc.; submission to FDA including prior approval, Changes Being Efficient (CBE); and creating annual reports.

Responsibilities

• Develop and execute regulatory plans for complex projects including new products and maintenance of licenses/authorizations for existing marketing authorizations

• Represent or lead the RA function on assigned cross-functional project teams

• Monitor applicable regulatory requirements; assure compliance with internal and external standards

• Establish appropriate communication within RA and other functions primarily at project level

• Perform gap analysis and propose solutions

• Develop and document sound regulatory decisions and justifications

• Ensure project teams and business objectives and deliverables are aligned with regulatory strategy

• May provide direct supervision of individuals

• May review promotional material or SOP’s for compliance with regulations

Qualifications:

• Bachelor’s degree in related scientific discipline with a minimum of 5 years regulatory experience in RA or related field, including managing people or projects. Higher degree/PhD will be an advantage.

• Proficiency in Documentum, SharePoint, Word, Excel, PowerPoint, Outlook

• Sound basis of regulatory knowledge and scientific knowledge

• Ability to manage complex projects and timelines in a matrix team environment

• Strong oral and written communication and presentation skills

• Demonstrated interpersonal skills including strong negotiation skills

• Ability to independently identify compliance risks and escalate when necessary

• Ability to lead and coach others

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

Perks of being a Kelly employee:

• Weekly electronic pay

• Access to more than 3,000 online training courses though Kelly Learning center

• Group rate insurance options available immediate upon hire*

• Service bonus plan and holiday pay*

• Online application system

• Never an applicant fee

*perks to be received upon meeting eligibility requirements

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com.

**Why Kelly** **®** **?**


With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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